Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy

NCT07719439 | Active Not Recruiting

• 2 other identifiers: 2026/158Duzce University (DÜBAP)
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study will assess whether perioperative short-term heart rate variability (HRV) indices and early inflammatory cytokine levels are associated with respiratory and cardiac adverse events in children undergoing elective adenoidectomy, tonsillectomy, or adenotonsillectomy under general anesthesia. HRV will be recorded noninvasively from 30 minutes before surgery until discharge from the post-anesthesia care unit. Serum cytokines will be measured from 3 mL of residual blood obtained after induction of anesthesia. The study aims to identify perioperative physiologic markers associated with a lower or higher risk of adverse events, thereby supporting safer anesthetic planning.

Conditions

Heart Rate Monitoring; Vagal Bradycardia; Adenotonsillar Hypertrophy; Tonsillitis; Hypertrophic; Adverse Cardiac Event; Respiratory Complication; Anesthesia

Outcome Measures

Primary Outcomes (1)

• HRV parameters' effect on perioperative cardiac events

  Association between perioperative HRV parameters and perioperative respiratory/cardiac adverse events. HRV measures: SDNN, RMSSD, LF, HF, and LF/HF derived from Holter/ECG recordings. Adverse events include laryngospasm, bronchospasm, apnea/hypopnea, breath-holding, hypoxemia/desaturation, stridor, severe cough, and clinically relevant cardiac events. Time Frame: From 30 minutes before surgery until discharge from the PACU, up to 1 day.

  1 day. Until discharge from the PACU (same day)

Secondary Outcomes (3)

• Association between early serum cytokine concentrations (IL-6, IL-8, IL-1beta, TNF-alpha, IL-10) and perioperative respiratory/cardiac adverse events

  1 day

• Association of HRV and PAED score after extubation

  30 minute after extubation

• Relationship of COLDS score and perioperative adverse events

  30 minutes

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

5-9 years, elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation * ASA physical status I-II; * Surgery planned under general anesthesia;

You may qualify if:

• Age 5-9 years;
• elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation
• ASA physical status I-II;
• surgery planned under general anesthesia;
• able to undergo standard endotracheal intubation and standard anesthetic protocol
• ; no dermatologic or cardiac barrier to preoperative Holter monitoring;
• written informed consent provided by parent/legal guardian.

You may not qualify if:

• ASA physical status III or higher; congenital heart disease, arrhythmia, or cardiac conduction disorder;
• known neurologic disease (e.g., epilepsy or cerebral palsy);
• psychiatric diagnosis;
• chronic inflammatory or immune-system disease;
• acute infection within 2 weeks before surgery
• regular steroid, immunosuppressive, or anti-inflammatory medication use;
• endocrine disease such as uncontrolled thyroid disease;
• preoperative hemodynamic instability;
• major unexpected intraoperative complication or ICU requirement;
• intraoperative atropine, lidocaine, beta-blocker, or epinephrine use;
• history of prematurity or syndromic disease;
• parent/legal guardian declines consent.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, 81620, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual serum samples(3 ml) obtained after induction of anesthesia will be centrifuged, stored at -80 degrees C, and analyzed for IL-6, IL-8, IL-1beta, TNF-alpha, and IL-10 by ELISA.

MeSH Terms

Conditions

Tonsillitis; Hypertrophy; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sultan Baran Erkul, PhD

  Duzce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)